AB0531 APPLYING THE WORKING DEFINITION OF THE DISEASE MODIFICATION CRITERIA TO LUPUS NEPHRITIS TREATMENTS FROM THE PUBLISHED LITERATURE
Authors: A. Askanase, R. Furie, M. Dall’era, A. Bomback, A. Schwarting, M. H. Zhao, I. N. Bruce, M. Khamashta, B. Rubin, A. Carroll, M. Daniels, R. Levy, R. Van Vollenhoven, M. B. Urowitz
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> We have recently published a working definition of disease modification in lupus nephritis (LN) as 'minimising disease activity with the fewest treatment-associated toxicities and slowing progression to end-stage kidney disease' <sup>[1]</sup>. As an increasing number of LN medications become available, classification of treatments as disease-modifying is critical in informing treatment decisions. <h3>Objectives</h3> To apply the proposed disease modification criteria to LN treatments. <h3>Methods</h3> Based on a review of a selection of LN clinical trial (n=21) and practice/observational publications (n=18) and authors' clinical experience, we determined whether the LN treatments satisfied the renal disease activity and organ damage disease modification criteria. The proposed disease modification criteria were examined at three time points as shown in the <b>Table 1</b>. <h3>Results</h3> All LN treatments met at least one of the renal disease modification criteria at any time point (<b>Table 1</b>), with hydroxychloroquine meeting the criteria for confirmed disease modification at &gt;5 years (no change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Index [SDI] or delayed progression beyond 5 years). Belimumab met more criteria across the three time points than any other biologic treatment. Based on the reviewed literature, many criteria were inconclusive or not available for evaluation. Glucocorticoids did not meet the disease modification criteria beyond 5 years given their negative impact on organ damage progression. <h3>Conclusion</h3> We examined the evidence in the literature for the disease modification potential of LN therapies at 1, 2–5, and &gt;5 years. Categorisation of treatments as disease-modifying is challenging, as studies use multiple agents, and study designs, patient populations, and endpoints/definition of renal response are not consistent between studies. The criteria allowed for the differentiation between LN therapies; future studies will evaluate the minimum number of criteria required to designate disease modification at each of the three time points, so that disease modification can be considered in the care of patients with LN and LN trial design. <h3>Reference</h3> [1]van Vollenhoven R et al. <i>Lupus Sci Med</i> 2022;9(1):e000634 <h3>Acknowledgements</h3> This review was funded by GSK. Medical writing support was provided by Casmira Brazaitis, PhD, and Cristina Teles, PhD, Fishawack Indicia Ltd, UK, part of Fishawack Health, and Hannah Jedrey, PhD, and Meer Basharat, PhD, TVF Communications Ltd, UK, and was funded by GSK. <h3>Disclosure of Interests</h3> Anca Askanase Consultant of: AbbVie, Amgen, AstraZeneca, Aurinia, BMS, Celgene, Eli Lilly, Idorsia, Janssen, Genentech, GSK, Mallinckrodt, Pfizer and UCB, Richard Furie Speakers bureau: AstraZeneca, Genentech/Roche, Consultant of: GSK, Aurinia, AstraZeneca, BMS, Genentech/Roche, Grant/research support from: GSK, Aurinia, AstraZeneca, BMS, Genentech/Roche, Maria Dall'Era Consultant of: GSK, AstraZeneca, Aurinia, Pfizer, Janssen, Andrew Bomback Consultant of: Alexion, Principio, Calliditas, Aurinia, Catalyst, Travere, GSK, Visterra, Silence, Novo Nordisk, Otsuka, ChemoCentryx, Novartis, Andreas Schwarting Speakers bureau: GSK, AstraZeneca, Pfizer, Novartis, Roche, Janssen, Boehringer Ingelheim, Grant/research support from: GSK, AstraZeneca, Pfizer, Novartis, Roche, Janssen, Boehringer Ingelheim, Ming-hui Zhao Consultant of: GSK, AstraZeneca, Novartis, Kira, Ian N. Bruce Speakers bureau: GSK, AstraZeneca, UCB, Consultant of: GSK, UCB, Eli Lilly, BMS, Merck Serono, Aurinia, IL-TOO, Grant/research support from: National Institute for Health Research (NIHR), GSK, Genzyme/Sanofi, MUNTHER KHAMASHTA Shareholder of: GSK, Employee of: GSK, Bernard Rubin Shareholder of: GSK, Employee of: GSK, Angela Carroll Shareholder of: GSK, Employee of: GSK, Mark Daniels Shareholder of: GSK, Employee of: GSK, Roger Levy Shareholder of: GSK, Employee of: GSK, Ronald van Vollenhoven Speakers bureau: AbbVie, Galapagos, GSK, Janssen, Pfizer, UCB, Roche, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, BMS, Galapagos, Gilead, Janssen, Pfizer, Sanofi, Servier, UCB, Vielabio, Grant/research support from: Pfizer, Roche, Murray B Urowitz Speakers bureau: GSK, AstraZeneca, Consultant of: GSK, AstraZeneca, Grant/research support from: GSK.